Product details
WHO Product ID
WHOAPI-290
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Hepatitis B and C
Type
None
Grade
Standard
INN
Sofosbuvir
Confirmation of WHO API prequalification document (version date)
Applicant organization
Tianish Laboratories Private Limited
Plot No. 564/A/22, Road No. 92, Jubilee Hills, Filmnagar, Shaikpet
Hyderabad,
Telangana
500096
India
APIMF Version Number
MLL/SOF/AP/001/03, April 2022
MLL/SOF/RP/001/03, April 2022
MLL/SOF/AP/001/03, April 2022/Amend-01, December 2023
MLL/SOF/RP/001/03, April 2022/Amend-01, December 2023
MLL/SOF/RP/001/03, April 2022
MLL/SOF/AP/001/03, April 2022/Amend-01, December 2023
MLL/SOF/RP/001/03, April 2022/Amend-01, December 2023
Product Grades
API specification number
STP/FPR/SOF/008/00
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Retest period
Packaging
Sofosbuvir is first packed in low density white polyethylene bag (LDPE), securely folded and twist-tied with a plastic rope, which is placed in another white polyethylene bag (HMLDPE) and heat sealed, then packed in a triple aluminium bag and finally placed in a HDPE drum.
API Manufacturing Site(s)
Tianish Laboratories Private Limited
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India